Aptima HCV RNA Qualitative Assay
FDA premarket approval P020011/S014 · decided 2019-06-21
Approval details
- PMA number
- P020011
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Aptima HCV RNA Qualitative Assay
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Applicant
- Gen-Probe
- Date received
- 2019-05-21
- Decision date
- 2019-06-21
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- MZP
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Transfer in-process, QC testing services for raw materials used in specific components to a separate contractor facility.
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